- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Phase classification, Trial completion date: Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (clinicaltrials.gov) - Apr 9, 2024
P2/3, N=200, Active, not recruiting,
Trial completion date: Feb 2024 --> Jun 2024 | Phase classification: P2b --> P2/3
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Preclinical, Journal: Comparative Immunogenicity and Neutralization Potency of Four Approved COVID-19 Vaccines in BALB/c Mice. (Pubmed Central) - Mar 13, 2024
Our results indicate significant immunogenicity and neutralization efficacy induced by PastoCovac Plus and Sinopharm, but not by Noora and SpikoGen. This suggests the need for additional comparative assessment of the potency and efficacy of these four vaccines in vaccinated subjects.
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Trial completion: FLINTER: Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera (clinicaltrials.gov) - Jan 22, 2024
P3, N=317, Completed,
Other efficacy and safety findings also indicated the similarity of two products. Active, not recruiting --> Completed
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Trial completion: RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - Nov 18, 2023
P3, N=140, Completed,
Overall, the study results confirmed that the current SpikoGen Active, not recruiting --> Completed
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Preclinical, Journal: Developmental and reproductive safety of Advax-CpG55.2 (Pubmed Central) - Sep 25, 2023
Reditux No evidence of antigen interference was observed when SpikoGen
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Journal: Ability of SpikoGen (Pubmed Central) - Sep 7, 2023
This resulted in high neutralisation including against the Omicron variants. This data supports ongoing use of SpikoGen
- |||||||||| Covovax (NVX-CoV2373) / Novavax, Takeda, Serum Institute of India
Review, Journal: Vaccination is the most effective and best way to avoid the disease of COVID-19. (Pubmed Central) - Sep 3, 2023
Among the vaccines that stimulate the host's immune system with the help of DNA are: undergoing Phase 2/3 trials including INO-4800 (International Vaccine Institute; Inovio Pharmaceuticals), Symvivo, Canada-COVID19 (AnGes, Inc.); GX-19 (Genexine, Inc.). BNT162b2
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment closed, Enrollment change: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Aug 25, 2023
P3b/4, N=39, Active, not recruiting,
Recruiting --> Completed | N=100 --> 43 Recruiting --> Active, not recruiting | N=400 --> 39
- |||||||||| CinnoVex (IFN-?-1a biosimilar) / CinnaGen
Journal: The effect of interferon in the therapy of severe coronavirus infection. (Pubmed Central) - Jul 3, 2023
Recruiting --> Active, not recruiting | N=400 --> 39 Based on the results of this study, the use of interferon in the treatment of COVID-19 can improve health and reduce the severity of the disease and mortality.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, cetuximab biosimilar / CinnaGen
Enrollment open, Trial completion date, Trial primary completion date, Metastases: Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux (clinicaltrials.gov) - Apr 5, 2023
P3, N=234, Recruiting,
This study aimed to evaluate the effectiveness of biosimilar teriparatide (CinnoPar Unknown status --> Recruiting | Trial completion date: Feb 2020 --> Feb 2026 | Trial primary completion date: Nov 2019 --> Nov 2025
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial completion date, Trial primary completion date: Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (clinicaltrials.gov) - Mar 30, 2023
P2b, N=200, Active, not recruiting,
Unknown status --> Recruiting | Trial completion date: Feb 2020 --> Feb 2026 | Trial primary completion date: Nov 2019 --> Nov 2025 Trial completion date: Mar 2023 --> Feb 2024 | Trial primary completion date: Oct 2022 --> Feb 2023
- |||||||||| CinnoPar (teriparatide biosimilar) / CinnaGen
Clinical, Journal: The efficacy of teriparatide (Cinnopar®) on bone repair in mandibular fractures: A single blinded randomized clinical trial. (Pubmed Central) - Jan 17, 2023
Teriparatide also had no effect on the postoperative complication rate in the control group (P > 0.05). Within the limitations of the study it seems that in mandibular fractures, teriparatide did not affect bone fusion or postoperative complications, so its use is not recommended for better bone fusion and fewer postoperative complications of mandibular fracture during the first month.
- |||||||||| CinnoVex (IFN-β-1a biosimilar) / CinnaGen
Retrospective data, Journal: Effectiveness of different treatment regimens on patients with COVID-19, hospitalized in Sanandaj hospitals: a retrospective cohort study. (Pubmed Central) - Jan 17, 2023
Within the limitations of the study it seems that in mandibular fractures, teriparatide did not affect bone fusion or postoperative complications, so its use is not recommended for better bone fusion and fewer postoperative complications of mandibular fracture during the first month. The study results showed the drug regimens 2 and 5 increased the days of hospitalization and hospitalization in ICU, respectively, while the other drug regimens had no significant effect on mortality and use a ventilator in the studied patients and none of the drug regimens had an effect on reducing mortality compared to other ones.
- |||||||||| CinnoRA (adalimumab biosimilar) / CinnaGen, Humira (adalimumab) / Eisai, AbbVie
Adalimumab Biosimilar (Cinnora) Efficacy for Management of Inflammatory Bowel Disease in Southwest of Iran (Lobby, East & West Wing, Grand Hyatt Incheon) - Dec 10, 2022 - Abstract #KDDW2022KDDW_569;
Conclusion Adalimumab has a positive effect on improving clinical symptoms; reducing disease activity; prevention of disease recurrent and need to colectomy in moderate to se- vere UC patients but has no efficacy in improvement of CD patients and failure of treat- ment observe in most of these patients. Adalimumab could be a therapeutic option for management of ulcerative colitis with prior failure of treatment.
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial completion, Trial completion date: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Oct 28, 2022
P2, N=39, Completed,
PK/PKPD analyses may contribute to PK similarity assessments. Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Jul 2022
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial completion, Phase classification, Head-to-Head: Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years (clinicaltrials.gov) - Oct 17, 2022
P3, N=581, Completed,
With some protocol modifications, it could lead to fewer patients’ referrals, saving time and money. Recruiting --> Completed | Phase classification: PN/A --> P3
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment open: Spikogen Booster Study (clinicaltrials.gov) - Oct 13, 2022
P3, N=150, Recruiting,
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P3 trial: Spikogen Booster Study (clinicaltrials.gov) - Sep 16, 2022
P3, N=150, Not yet recruiting,
- |||||||||| Cinnal F (follitropin alfa biosimilar) / CinnaGen
Journal: Superovulation of high-producing Holstein lactating dairy cows with human recombinant FSH and hMG. (Pubmed Central) - Sep 10, 2022
However, pregnancy rates on Day 60 and the number of calves born healthy was less in heifers that received embryos from Cinnal-f treated donors (P < 0.05). In conclusion, Cinnal-f and Menotropins could provide similar superovulatory response to Folltropin-V for superovulation of high-producing Holstein lactating dairy cows.
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment open, Trial completion date: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Aug 18, 2022
P3b/4, N=400, Recruiting,
In conclusion, Cinnal-f and Menotropins could provide similar superovulatory response to Folltropin-V for superovulation of high-producing Holstein lactating dairy cows. Not yet recruiting --> Recruiting | Trial completion date: Aug 2023 --> Dec 2023
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen, COVIran Barekat / Barakat Pharma
Introducing the recent developments in the production of various COVID-19 vaccines in Iran () - Jul 16, 2022 - Abstract #IVCMG2022IVC_MG_19;
The most famous Iranian Covid-19 Vaccine brands are COVIran Barekat, PastoCovac, Spikogen, Razi, and Fakhra which all the, have more than 80% efficiency according to recent research and national statistics and have been welcomed by the people themselves...In this speech, we are going to talk about the types of COVID 19 vaccines produced in Iran, their effectiveness, and specifications. Audience Take Away: An overview of the different types of COVID-19 vaccines produced Description of vaccines produced in Iran, their characteristics and effectiveness Investigating the relationship between coronavirus mortality statistics and the amount and types of vaccines used in different communities Steps and difficulties of producing a new vaccine in the event of an epidemic
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Phase classification, Enrollment change: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Jul 5, 2022
P3b/4, N=400, Not yet recruiting,
Audience Take Away: An overview of the different types of COVID-19 vaccines produced Description of vaccines produced in Iran, their characteristics and effectiveness Investigating the relationship between coronavirus mortality statistics and the amount and types of vaccines used in different communities Steps and difficulties of producing a new vaccine in the event of an epidemic Phase classification: P2/3 --> P3b/4 | N=200 --> 400
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Enrollment closed, Trial completion date, Trial primary completion date: FLINTER: Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera (clinicaltrials.gov) - Jun 2, 2022
P3, N=317, Active, not recruiting,
Large prospective controlled studies and real-life data with longer follow-up are needed to document the non-inferiority of RED compared to MAB. Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Mar 2023 | Trial primary completion date: Sep 2020 --> Sep 2022
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial initiation date, Trial primary completion date: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (clinicaltrials.gov) - May 19, 2022
P2/3, N=200, Not yet recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Mar 2023 | Trial primary completion date: Sep 2020 --> Sep 2022 Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2023 --> Jul 2023
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment closed: Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (clinicaltrials.gov) - May 18, 2022
P2b, N=200, Active, not recruiting,
Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2023 --> Jul 2023 Recruiting --> Active, not recruiting
- |||||||||| Rebif (human IFN-β-1a) / EMD Serono, CinnoVex (IFN-β-1a biosimilar) / CinnaGen
Journal: Comparative Toxicity of Interferon Beta-1a Impurities of Heavy Metal Ions. (Pubmed Central) - May 1, 2022
It was hypothesized that the IFNβ-1a complex binds heavy metals affecting the tertiary protein structure and may lead to some side effects of drug administration. Further testing of IFNβ-1a bioequivalence for parenteral application is necessary.
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